Oxlumo® (lumasiran) Injection

Oxlumo (lumasiran) is covered for pediatric and adult treatment of primary hyperoxaluria type 1 (PH1) when there is genetic confirmation of an AGXT mutation and objective biochemical evidence of elevated oxalate (urinary oxalate ≥0.5 mmol/24h/1.73 m^2 with no secondary oxalate sources, or urine oxalate:creatinine above age-specific ULN, or plasma oxalate ≥20 µmol/L); therapy is excluded for patients with a prior liver transplant for PH1. Key requirements: prescribing or consultation by a nephrologist/urologist, documentation of the specified genetic and oxalate results and patient weight for the required weight-based dosing, initial approval for 6 months with 12-month renewals contingent on demonstrated clinical/biochemical benefit.

"Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients."